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Completed

NCT Number: NCT01546675

Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

The purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization. The investigators comparisons included assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel high-speed, high-resolution, bi-plane video radiography system.

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Key information

Conditions

Traumatic Amputation of Arm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY, New York, United States

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About this study

In the past decade, advances in upper limb socket design and technology have been proposed to increase comfort and decrease perceived weight of the prosthesis. There have been no scientific studies to date that have evaluated the benefits of these designs, and thus no evidence to support use of one type of prosthetic socket design over another. Thus, the overall purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users.

Exclusion criteria

  • Subjects with frozen shoulder of the residual side, and/or severely limited active range of motion of the shoulder joint of the residual limb
  • Inability to tolerate wearing of a prosthetic socket
  • Mental impairment that renders a subject unable to comply with the study
  • Skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevent prior prosthetic wear
  • Any electrically controlled medical device including pacemaker, implanted defibrillator or drug pumps
  • Neuropathy, uncontrolled diabetes, receiving dialysis
  • Any other significant comorbidity which would interfere with the study
  • Severe circulatory problems including peripheral vascular disease and pitting edema will be excluded
  • Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
  • Women who are pregnant or who plan to become pregnant in the near future

Treatment and study plan

Skeletal Stabilization

Other

Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization

Other names: Skeletal Stabilization Socket

Primary outcomes

  1. Degrees of Shoulder Abduction Within the Prosthetic Socket

    Time frame: After 4 weeks of home use (2 weeks for each socket style)

    Shoulder abduction was performed to the subject's maximum elevation. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

  2. Degrees of Shoulder Internal Rotation Within the Prosthetic Socket

    Time frame: After 4 weeks of home use (2 weeks for each socket style)

    Isometric internal rotation was performed with the prosthetic elbow flexed to 90 degrees and shoulder in neutral position. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

  3. Degrees of Shoulder Displacement Within the Prosthetic Socket

    Time frame: After 4 weeks of home use (2 weeks for each socket style)

    A shoulder shrug task was achieved by pulling up on a strap attached to the load cell, which was mounted on the vertical face of the concrete pedestal. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

Secondary outcomes

  1. Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)

    Time frame: After 4 weeks of home use (2 weeks for each socket style)

    This 10 item scale includes items related to satisfaction with aspects of the prosthesis. It includes questions about extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated on a 5 point scale from very dissatisfied to very satisfied. Scores are summed and the average of the 10 items are calculated. Higher scores indicate greater satisfaction. Scores range from 1-5.

  2. Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale

    Time frame: after 2 weeks of home use of each socket type

    The 8-item utility subscale includes items related to prosthetic socket utility including: comfort, fit, ease of donning and doffing and feel on the residual limb. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.

  3. Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale

    Time frame: After 4 weeks of home use (2 weeks for each socket style)

    The 6-item residual limb health scale includes items about the bothersome of sweating, smell, swelling, ingrown hairs, rashes and blisters. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Collaborators

  • Brown University
  • Lifespan

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 7, 2012
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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